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联动成像技术在上消化道肿瘤检出中的应用:一项随机试验
联动成像技术在上消化道肿瘤检出中的应用:一项随机试验
联动成像技术在上消化道肿瘤检出中的应用:一项随机试验
Linked Color Imaging Focused on Neoplasm Detection in the Upper Gastrointestinal Tract : A Randomized Trial
S Ono, K Kawada, O Dohi, S Kitamura… - Annals of Internal Medicine, 2021
LCI比WLI更能有效地检测咽、食管和胃的肿瘤病变。
Conclusions: LCI is more effective than WLI for detecting neoplastic lesions in the pharynx, esophagus, and stomach.
01
背景
联动成像技术(LCI)是一种新的图像增强内镜技术,可以让使用者识别出黏膜颜色的微小差异。
Background: Linked color imaging (LCI) is a new image-enhanced endoscopy technique that allows users to recognize slight differences in mucosal color.
02
目的
比较LCI与白光成像(WLI)检测上消化道肿瘤病变的效果。
Objective: To compare the performance of LCI with white light imaging (WLI) in detecting neoplastic lesions in the upper gastrointestinal tract.
03
设计
采用最小化随机化的多中心对照试验。
Design: A controlled, multicenter trial with randomization using minimization.
04
地点
日本16所大学医院和3所三级护理医院。
Setting: 16 university hospitals and 3 tertiary care hospitals in Japan.
05
患者
1502例既往或目前已知的胃肠道肿瘤患者,正在接受胃肠道肿瘤监测。
Patients: 1502 patients with known previous or current cancer of the gastrointestinal tract and undergoing surveillance for gastrointestinal cancer.
06
方法
WLI组(WLI组)或LCI组(LCI组)。
Intervention: WLI followed by LCI examination (WLI group) or LCI followed by WLI examination (LCI group).
07
测量
在第一次检查中诊断出1个或1个以上的咽、食管或胃肿瘤病变(主要结果),在第一次检查中诊断出1个或1个以上的肿瘤病变(次要结果)。
Measurements: Diagnosis of 1 or more neoplastic lesions in the pharynx, esophagus, or stomach in the first examination (primary outcome) and 1 or more neoplastic lesions overlooked in the first examination (secondary outcome).
08
结果
WLI组752例,LCI组750例。 在首次检查中诊断出1个或1个以上肿瘤病变的患者中,LCI患者的比例高于WLI患者(750例患者中有60例,8.0% [95% CI, 6.2% - 10.2%] vs 752例患者中有36例,4.8% [CI, 3.4% - 6.6%]; 风险比,1.67 [CI, 1.12 - 2.50; P = 0.011)。 LCI组肿瘤的漏诊率低于WLI组(750例患者中有5例,0.67% [CI, 0.2%至1.6%] vs 752例患者中有26例,3.5% [CI, 2.3%至5.0%]; 风险比,0.19 [CI, 0.07 ~ 0.50])。
Results: 752 patients were assigned to the WLI group and 750 to the LCI group. The percentage of patients with 1 or more neoplastic lesions diagnosed in the first examination was higher with LCI than with WLI (60 of 750 patients or 8.0% [95% CI, 6.2% to 10.2%] vs. 36 of 752 patients or 4.8% [CI, 3.4% to 6.6%]; risk ratio, 1.67 [CI, 1.12 to 2.50; P = 0.011]). The proportion with overlooked neoplasms was lower in the LCI group than in the WLI group (5 of 750 patients or 0.67% [CI, 0.2% to 1.6%] vs. 26 of 752 patients or 3.5% [CI, 2.3% to 5.0%]; risk ratio, 0.19 [CI, 0.07 to 0.50]).
09
局限性
内镜检查人员并未进行单盲设置。
Limitation: Endoscopists were not blinded.
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